Limbrel FDA Alert

  • On December 21, 2017, Primus Pharmaceuticals, in response to unwarranted pressure from the FDA, has voluntarily suspended promotion and sale of Limbrel, an important and in many cases the only medical option for people suffering from osteoarthritis, pending Primus receiving requested safety data held by the FDA and meeting with the FDA as requested.

  • Primus’ letter to the FDA setting forth this step was taken in response to repeated aggressive press releases from the FDA and a letter from the FDA to Primus received on December 19, 2017.

  • The FDA claims safety as the basis of its unilateral actions, but the incidence, severity and reversibility of these adverse events from 13 years of in-market experience are contrary to the aggressive and far-reaching conclusions taken by the FDA.

  • Recognized scientific and medical experts have written opinion letters to the FDA supporting the urgency of continued access to Limbrel based on clinical trial and real-world medical experience with Limbrel, based on the scientific and medical literature, which establishes that the adverse events the FDA has publicized are reversible and not life threatening, and based on the established safety record of Limbrel, which shows that the rare adverse events at issue for Limbrel are of much less concern than the known adverse effects for alternative osteoarthritis (OA) treatments, NSAIDs and opioids.

  • The FDA’s “preliminary evaluation” of Limbrel’s medical food status appeared to have somehow moved to a final determination of unapproved new drug status without ever reviewing Primus’ extensive distinctive nutritional requirements analyses for OA that Primus offered to the FDA.

  • Limbrel is representative of the type of innovation in nutrition and patient care Congress intended to stimulate when it enacted the statutory definition of a medical food in 1988. If the FDA and industry could work together and the FDA be open to innovation, medical foods provide a great opportunity to advance public health while reducing total costs of care.

  • The FDA appears to disregard the major public health implications of Limbrel because it is the only prescription product that can be safely taken by big segments of the population with OA. Many OA sufferers cannot take NSAIDs and want to avoid opioids. Established by expert opinion letters, not only is Limbrel significantly safer than alternative options for osteoarthritis, Limbrel is for many elderly patients the only hope for relief from osteoarthritis.

  • Primus is doing all that it can to cooperate with the FDA, which to-date has been uncooperative and has operated under a veil of secrecy.

  • Primus hopes that the FDA will provide the information that Primus has requested to permit independent expert analysis of the basis for FDA’s actions, and to meet with FDA in the near future to make the continued distribution of Limbrel to those patients in need possible.

Click here to tell your story about why you need Limbrel

Or mail a letter that Primus will forward to the FDA:
Primus Pharmaceuticals, 7373 N. Scottsdale Road, Suite B-200, Scottsdale, AZ 85253

Refund Questions?

Limbrel is a prescription medical food product for the clinical dietary management of the metabolic processes of osteoarthritis (OA). Physician supervision required.
Limbrel is not an NSAID, nor a COX-2 selective inhibitor.
U.S. Patent No. 5,516,925; 7,192,611; 7,514,469; 7,838,042; 7,972,632; and 8,124,134; other patents pending.

©2017 Primus Pharmaceuticals, Inc. All rights reserved. | Disclaimer | Privacy Policy | Terms of Use. This site is intended for U.S. residents only. *Data on file.